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The Learned Intermediary Doctrine: Uniformity at Last?

By Emily Ullman and Annie Wang
April 01, 2016

State and federal courts have long faced the difficulty of adapting purchaser-focused product liability doctrines to the pharmaceutical and medical device areas, where physicians mediate the interaction between the manufacturer and the ultimate consumer, the patient. First articulated in 1948 in Marcus v. Specific Pharmaceuticals, Inc., 77 N.Y.S.2d 508 (App. Div. 1948), the learned intermediary doctrine addresses this dilemma by providing that manufacturers of prescription medicines need warn only physicians of the relevant risks associated with their products. Manufacturers are not required to give warnings directly to patients. Premised on the principle that a prescribing physician stands in the best position to evaluate a patient's medical history and assess the risks and benefits of a particular treatment, this rule embraces the FDA's determination that medical products available only by prescription have inherent and unavoidable risks requiring a physician's approval prior to use.

At the turn of 2016, 35 states and the District of Columbia had adopted the learned intermediary doctrine in the pharmaceutical context, either through legislation or their highest court. See Centocor Inc. v. Hamilton, 372 S.W.3d 140, 158 n.17 (Tex. 2012); see also Br. of Amicus Curiae Pharm. Research & Mfrs. of Am. in Supp. of Pet. for Review, Centocor, Inc. v. Hamilton, No. 10-0223, at App'x A (Tex. May 20, 2010). The majority of the remaining states either applied the rule in the lower courts or remained silent on the issue, leaving federal courts to predict that the doctrine would be applied through an Erie analysis. See, e.g., Greaves v. Eli Lilly & Co., 503 F. Appx. 70, 71-72 (2d Cir. 2012).

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